Peptides are becoming increasingly useful in basic research and clinical practice. Interest in peptides can be attributed to their role as mediators in many biological pathways and to their unique intrinsic properties. For example, many peptides have high specificity for their target with low non-specific binding to molecules that are not targeted, thus minimizing drug-drug interactions, and many peptides show low accumulation in tissues over time, thus reducing side effects. Moreover, peptides are often broken down in vivo to their constituent amino acids, thus reducing the risk of complications due to toxic metabolic intermediates.
Peptide market values are generally grouped within five broad categories in the life sciences field: cytokines, enzymes, hormones, monoclonal antibodies, and vaccines. According to a 2008 Frost & Sullivan market research report, these broad categories can be further subdivided in the United States into vaccines (34%), monoclonal antibodies (30%), recombinant hormones and proteins (10%), gene therapy (6%), cell therapy (4%), antisense (3%), interferons (3%), interleukins (2%), growth factors (1%), and others (7%). Each of these categories is undergoing high growth rates. For example, from 2004 to 2007, the monoclonal antibody market alone almost doubled its revenue from $6.3 billion to $12.6 billion. In addition, several new products, including Bydureon® (exenatide LAR for diabetes; Amylin/Eli Lilly), Extavia® (interferon beta-1b for multiple sclerosis; Novartis), and Simponi™ (golimumab for rheumatoid and psoriatic arthritis; Centocor) have been approved recently by the FDA.
Moreover, peptide markets are likely to continue to grow. For example, of 633 drugs in development in 2008, nearly half were peptides. Analysts estimate an eight percent compound annual growth rate over the next half-decade resulting in a potential $20 billion in earnings for the year 2013, representing nearly fifteen percent of the forecast total earnings for the biopharmaceuticals market. Additional opportunities exist for peptides as reagents in basic research and diagnostic platforms.
While advances in the field of peptide science have led to impressive commercial growth, several barriers remain to be overcome. For example, peptides tend to have delivery and stability problems compared to traditional small molecule therapeutics. Attempts to address these problems have involved oral, nasal, and pulmonary delivery. However, these attempts often require higher doses of the peptides or yield unfavorable pharmacokinetic profiles.
One of the biggest barriers to increased use of peptides is the cost of the peptides themselves, which is generally significantly higher than the cost of producing small molecule therapeutics. For instance, Nutropin AQ®, a form of recombinant human growth hormone manufactured by Genentech and administered to patients with growth defects during adolescence, costs $30,000 annually. High prices are an even bigger barrier to obtaining peptides when the peptide is used for research purposes. For example, β-amyloid (1-42) peptide is a research peptide with strong implications in the onset of Alzheimer's disease. A survey of prices from various peptide manufacturers finds the price of research-grade β-amyloid (1-42) ranging from $225/mg (21st Century Biochemicals) to $1,490/mg (Sigma-Aldrich), with the typical price at $300-$320/mg (AnaSpec, California Peptide, Innovagen, rPeptide) (estimated 2009 prices as obtained from catalogs).
Due to the importance of peptides and their high price, there is a persistent and long-felt yet unfulfilled need for lowering the cost of peptides. The industrial and medical use of peptides has created a need for an improved means of production and purification, where the improvement may be in efficiency, price, and/or quality of product. Accordingly, the present invention is directed to processes for the production of peptides, and the peptides produced. Methods of marketing peptides are also disclosed.